Kornimate/medical-research-clean huggingface dataset:
ceftobiprole in the treatment of resistant staphylococcus aureus skin and skin structure infections

Conditions: Skin Diseases, Infectious; Skin Diseases, Bacterial; Staphylococcal Skin Infections

Summary: the purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections. the study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in patients with complicated skin and skin structure infections.

ceftobiprole medocaril is a cephalosporin antibiotic with anti-mrsa (methicillin-resistant staphylococcus aureus) activity. ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections. this is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections. the patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. the patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator. the primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. the patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility criteria:
inclusion criteria: * diagnosis of an infection consistent with complicated skin and skin structure infections. exclusion criteria: * known or suspected hypersensitivity to any study medication or other related anti-infective medication * any known or suspected condition or concurrent treatment contraindicated by the prescribing information * previous enrollment in this study * treatment with any investigational drug within 30 days before enrollment

Keywords: complicated skin infections infectious skin diseases bacterial skin diseases staphylococcal skin infections cephalosporin
efficacy and safety of divozilimab in patients with neuromyelitis optica spectrum disorders (aquarelle)

Conditions: Neuromyelitis Optica Spectrum Disorders

Summary: the goal of this clinical trial is to study the efficacy and safety of bcd-132 (divozilimab) in subjects with neuromyelitis optica spectrum disorders (nmosd).

bcd-132-6/aquarelle is an open-label phase 3 clinical study in subjects with nmosd. approximately 105 subjects will be enrolled. the study consists of a screening period, a treatment period and a follow-up period. during treatment period, the subjects will receive the investigational product divozilimab. the duration of participation for each subject will be approximately 104 weeks.

Eligibility criteria:
inclusion criteria: * nmosd diagnosed based on the 2015 nmosd international consensus diagnostic criteria * documented evidence of at least 1 relapse within 12 months before signing the informed consent form, or 2 relapses within 24 months before signing the informed consent form * a total edss score of ≤ 7 * presence of igg antibodies to the varicella zoster virus at screening * a cd19+ cell proportion of ≥ 1 % of the total lymphocyte count in patients exposed to other anti-b-cell therapies more than 6 months before signing the informed consent form exclusion criteria: * a relapse occurring less than 30 days before signing the informed consent form or at screening (patients may be re-screened) * intrathecal oligoclonal or monoclonal igg production (in patients who are anti-aqp4 seronegative) * other nervous system disorders (including multiple sclerosis) that can mask or affect the assessment of nmosd symptoms * history of other autoimmune diseases requiring immunosuppressive therapy * prior exposure to: alemtuzumab, total lymphatic irradiation, bone marrow transplantation; anti-b-cell therapy drugs, abatacept, satralizumab within 6 months prior to signing the informed consent form; mitoxantrone, cyclophosphamide, methotrexate, cyclosporine a, tacrolimus, eculizumab, tocilizumab, natalizumab, interferon beta, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate within 3 months before signing the informed consent form; immunoglobulin products within 30 days before signing the informed consent form; transfusion of blood or blood components within 30 days before signing the informed consent form; systemic corticosteroids at the time of signing the informed consent form
impact of gum acacia on chronic kidney disease patients

Conditions: Chronic Kidney Diseases

Summary: the aim of the study is to evaluate the impact of gum acacia on serum levels of protein-bound uremic toxins (indoxyl sulfate and p-cresyl sulfate).in addition to the evaluation of its effect on metabolic profile and disease progression in chronic kidney disease patients.

1. ethical committee approval has been obtained from ethics committee of faculty of medicine, alexandria university. 2. all participants should agree to take part in this clinical study and will provide informed consent. 3. eighty chronic kidney disease patients,will be recruited from the kidney and urology center (kuc) and alexandria main university hospital (amuh). the 80 participants will be randomly assigned into 2 arms. control arm (n=40): will be treated with standard treatment without any herbal intervention. intervention arm (n=40): will be treated with standard treatment in addition to gum acacia sachets. each sachet contains 25 g of gum acacia powder to be taken on daily-basis for 3 months. 4. all patients will be submitted to : * full patient history and clinical examination. * blood withdrawal in order to conduct lab work. 5. patients demographic data will be recorded with respect to age, weight and other co-morbidities. 6. statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 7. results, conclusion, discussion and recommendations will be given.

Eligibility criteria:
inclusion criteria: * non-hemodialysis ckd patients (stage iii -v) * age: above 18 years exclusion criteria: * hemodialysis patients * pregnancy \& lactation * patients recently treated with antibiotic regimen (2 - 4 weeks) * malignancy * inflammatory bowel disease
continuous glucose monitoring combined with computer algorithm for intensive insulin therapy in cardiosurgical patients

Conditions: Hyperglycemia; Cardiac Surgery

Summary: the purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.


Eligibility criteria:
inclusion criteria: * elective cardiac surgery exclusion criteria: * insulin allergy * mental incapacity * language barrier

Keywords: continuous glucose monitoring intensive insulin therapy critically ill cardiac surgery hyperglycemia of critically ill
optimal adalimumab plasma concentrations in ankylosing spondylitis patients

Conditions: Ankylosing Spondylitis

Summary: the optimal plasma concentration range of adalimumab in chinese patients with active ankylosing spondylitis remains unknown, the aims of this study is to determine the concentration-effect relationship, and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting.

this prospective observational study will include chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment. the primary outcome is the mean change from baseline in ankylosing spondylitis disease activity score (asdas).

Eligibility criteria:
inclusion criteria: 1. consent of the patient. 2. patient who meets the definition of ankylosing spondylitis based on the 1984 modified new york criteria, has a diagnosis of active ankylosing spondylitis (basdai ≥ 4, back pain ≥ 4). 3. patients who have indication of adalimumab. 4. patients on nsaids treatment need to be on a stable dose for at least 4 weeks. exclusion criteria: (1) hepatitis b or tuberculosis patients

Keywords: ankylosing spondylitis adalimumab
assessment of cardiopulmonary function in duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: this study seeks to develop and validate non-invasive assessments of cardiac and respiratory muscles with magnetic resonance imaging (mri) to better predict the natural disease progression of duchenne muscular dystrophy (dmd) in affected individuals over time, as well as determine whether peripheral skeletal muscle dysfunction can predict cardiopulmonary dysfunction. the central hypothesis is that non-invasive mri measures of the heart, muscle, and peripheral skeletal muscles can sensitively predict future cardiopulmonary decline.

magnetic resonance imaging (mri) of the heart and breathing muscles, special breathing tests (called pulmonary function testing), special exercise tests (using a stationary bike), and possibly an echocardiogram (ultrasound of the heart, commonly known as an "echo") will be completed up to 4 times per year for up to 4 years. most participants will complete testing once or twice each year; however, some participants will be asked to repeat some of the tests twice during each visit.

Eligibility criteria:
inclusion criteria: * male * 5-15 years old at the time of enrollment * diagnosed with dmd (as defined by parent project) * written parental informed consent (and assent where appropriate) before any study procedures take place exclusion criteria: * contraindication to an mri examination * presence of a secondary condition that impacts muscle function or metabolism, that leads to developmental delay or impaired motor control, or that is not stable * participant is unable to comply with study requirements * congenital structural abnormality of the heart, repaired or unrepaired * clinically contraindicated participation
ischemic conditioning chronic stroke study

Conditions: Stroke

Summary: stroke is the leading cause of disability in adults in the united states. despite advances in hyperacute stroke care, advancements in stroke rehabilitation are lagging. we have previously shown that a non-invasive, cost-effective, easy to perform intervention, called ischemic conditioning (ic), can improve paretic leg strength, reduce muscle fatigue, and increase walking speed in chronic stroke survivors (\>1 year post-stroke). the ic procedure makes the paretic leg transiently ischemic (5 minutes) using a cuff inflated to 225 mmhg, and repeats the occlusion 5 times with 5 minute periods of rest between cycles (45 total minutes). it is well accepted that the response to ic is complex and involves local, humoral and neural factors. the mechanism by which ic can confer motor benefit in stroke survivors is unknown. the aim of this study is to examine if ic can increase sympathetic nervous system (sns) activity, which would promote an increased cardiovascular response to exercise and increased muscle strength. we hypothesize that plasma epinephrine and norepinephrine levels will increase more during a cold pressor test (a well-tolerated test to induce a sympathetic response) in chronic stroke survivors who undergo a single session of ic vs. ic-sham. to accomplish the goals of this study, 15 chronic stroke survivors will each make two visits to the adult translational research unit at medical college of wisconsin (mcw) to have either ic or ic-sham performed on their paretic leg in a counterbalanced order. venous blood will be drawn before and after the ic or ic-sham procedure and after a two-minute cold pressor test where the study participants submerge their hand into a bucket of ice water. this will cause an increased sympathetic response, which will be assessed by measuring blood pressure and the relative increase in the levels of circulating catecholamines (epinephrine and norepinephrine, assessed by high performance liquid chromatography).


Eligibility criteria:
inclusion criteria: * study participants must be between 18-85 years of age, able to give informed consent, \>1 year post diagnosis of unilateral cortical or sub-cortical stroke, have residual lower limb paresis. exclusion criteria: * history of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. wounds in the leg), chronic pain syndrome, history of head trauma, comorbid neurological disorder, any uncontrolled hypertension (\>160/100 mmhg), peripheral vascular disease, a myocardial infarction in the previous year, inability to follow 2 step commands, or history of multiple strokes.
advance mpi 1: study of regadenoson versus adenoscan® in patients undergoing myocardial perfusion imaging (mpi)

Conditions: Coronary Artery Disease

Summary: adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. the investigational drug, regadenoson (cvt-3146) is a selective a2a adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (mpi) studies. this study will compare the safety and efficacy of regadenoson to that of adenoscan in detecting reversible myocardial perfusion defects.

advance mpi 1 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in spect mpi compared to that of the approved pharmacological stress agent, adenoscan. patients referred for a clinically indicated pharmacological stress mpi study will be eligible for enrollment. the trial is designed: * to compare the pharmacological stress spect images obtained with regadenoson to those obtained with adenoscan, and * to compare the safety and tolerability of the two stress agents.

Eligibility criteria:
inclusion criteria: * referred for a clinically indicated pharmacological stress spect myocardial perfusion imaging study exclusion criteria: * any condition precluding the safe administration of adenoscan for a spect myocardial perfusion imaging study * pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control

Keywords: lexiscan regadenoson adenoscan® adenosine spect myocardial perfusion imaging reversible perfusion defect
prinomastat and combination chemotherapy in treating patients with metastatic or recurrent non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: prinomastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die. purpose: randomized phase iii trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer.

objectives: i. compare the overall survival, progression free survival, symptomatic progression free survival, and one year survival of patients with metastatic or recurrent non-small cell lung cancer treated with prinomastat (ag3340) or placebo in combination with gemcitabine and cisplatin. ii. compare the disease response and duration of response in these patients on these regimens. iii. compare the quality of life of these patients on these regimens. iv. evaluate the safety of these regimens in these patients. outline: this is a randomized, double blind, placebo controlled, multicenter study. patients receive oral prinomastat or placebo twice daily beginning on day 1, followed by gemcitabine iv on days 1 and 8 and cisplatin iv on day 1. courses repeat every 3 weeks. projected accrual: approximately 420 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: stage iv or recurrent or t4 lesion non-small cell lung cancer measurable or evaluable disease no brain metastases patient characteristics: age: 18 and over performance status: who 0-1 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy for non-small cell lung cancer endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: recurrent non-small cell lung cancer stage iv non-small cell lung cancer
clinical trials of footwear in patients with diabetes-study arm 2,3

Conditions: Diabetic Foot Ulcers

Summary: this is a randomized clinical trial to: (1) determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) estimate costs of ulcer prevention using these strategies.

this is a randomized clinical trial to: (1) determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) estimate costs of ulcer prevention using these strategies. patients from the seattle va (n=214) and group health cooperative (n=213) will be randomly assigned to one of two study arms. they are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.

Eligibility criteria:
diabetics with foot ulcerations

Keywords: foot ulcers, amputation prevention, diabetes, footwear, insoles
effect of oral enteral nutrition on cerebral small vessel disease

Conditions: Cerebral Small Vessel Diseases

Summary: nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. compared to ngt, ioe, as an enteral nutrition support mode, in csvd patients with dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, adl, qol, pneumonia, and adverse events, which should be considered as the preferred approach.

nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. this was a randomized controlled study with 60 csvd patients with dysphagia who received comprehensive rehabilitation therapy. patients enrolled were randomly divided into the observation group (with ioe, n=30) and the control group (with ngt, n=30). at admission and after treatment, video fluoroscopic swallowing study (vfss) and functional oral intake scale (fois), body mass index (bmi), serum albumin (alb), and hemoglobin (hb), modified barthel index (mbi) and world health organization quality of life assessment instrument brief version (whoqol-bref) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (adl) and quality of life (qol). the incidence of pneumonia was recorded and compared.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebral small vessel disease; * must be able to cooperate with treatment and questionnaire investigation; * clinical diagnosis of dysphagia through the functional oral intake scale (fois) and video fluoroscopic swallowing study (vfss); * age between 40 and 70 years; * enteral nutrition support was required and feasible. * no history of prior stroke. exclusion criteria: * dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases; * complicated with severe liver and kidney failure, tumors, or hematological disorders; * simultaneously need to undergo other therapy that might affect the outcomes of this study; * pregnant or nursing females.
prospective trial to compare adr of g-eye™ colonoscopy with standard colonoscopy

Conditions: Adenoma; Polyps; Colorectal Cancer

Summary: the purpose of this study is to compare the adenoma detection rate (adr) of the g-eye™ colonoscopy with that of standard colonoscopy.

this is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing g-eye™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy. the study will enroll 350 subjects. consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria. subjects will sign an informed consent form and undergo randomization.

Eligibility criteria:
inclusion criteria: 1. patients over 50 years old 2. referred to colonoscopy for screening, following positive fobt testing, change of bowel habits, for diagnostic evaluation or for surveillance colonoscopy (history of adenoma resection). 3. the patient must understand and provide written consent for the procedure. exclusion criteria: 1. subjects with inflammatory bowel disease; 2. subjects with a personal history of polyposis syndrome; 3. subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. subjects with diverticulitis or toxic megacolon; 5. subjects with a history of radiation therapy to abdomen or pelvis; 6. pregnant or lactating female subjects; 7. subjects who are currently enrolled in another clinical investigation. 8. subjects with current oral or parenteral use of anticoagulants that have not stopped using anticoagulants as required by the guidelines of the medical center; 9. subjects with recent (within the last 3 mounts) coronary ischemia or cva (stroke) 10. any patient condition deemed too risky for the study by the investigator 11. previous colonic surgery (except for appendectomy)

Keywords: adenoma polyp crc colonoscopy detection yield